# K001951: Primed Pleated Tie-Back, Procedure Mask PM4-305, Primed Pleated Ear-Loop, Procedure Mask PM4-306

- Pathway: 510(k) (Traditional)
- Applicant: Primeline Medical Products, Inc.
- Decided: Sep 8, 2000 after 73 days
- Product code: FXX (Mask, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K081633: Primagard 80, 120, 160 Fluid Resistant Procedure/Surgical Face Masks (2008), 3 descendants of its own
- K240286: PRIMED Surgical Masks and PRIMED Procedure Masks (2024), 1 descendant of its own
- K252964: PRIMED Surgical and Procedure Masks (2025), 0 descendants of its own
- K092012: Primagard Delta Fit 80,120, 160  Surgical Face Mask (Small, Medium, Large) Model PG4-7061,-7071,-7081, PG4-7062, 7072-70 (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K001951
Methodology: https://510kreport.com/methodology